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Lookup NU author(s): Rebecca Maier, Professor Luke ValeORCiD, Dr Leanne Marsay, Professor Helen HancockORCiD, Professor Enoch AkowuahORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.Numbers of patients undergoing mitral valve repair (MVr) surgery for severe mitral regurgitation have grown and will continue to rise. MVr is routinely performed via median sternotomy; however, there is a move towards less invasive surgical approaches. There is debate within the clinical and National Health Service (NHS) commissioning community about widespread adoption of minimally invasive MVr surgery in the absence of robust research evidence; implementation requires investment in staff and infrastructure. The UK Mini Mitral trial will provide definitive evidence comparing patient, NHS and clinical outcomes in adult patients undergoing MVr surgery. It will establish the best surgical approach for MVr, setting a standard against which emerging percutaneous techniques can be measured. Findings will inform optimisation of cost-effective practice. UK Mini Mitral is a multicentre, expertise based randomised controlled trial of minimally invasive thoracoscopically guided right minithoracotomy versus conventional sternotomy for MVr. The trial is taking place in NHS cardiothoracic centres in the UK with established minimally invasive mitral valve surgery programmes. In each centre, consenting and eligible patients are randomised to receive surgery performed by consultant surgeons who meet protocol-defined surgical expertise criteria. Patients are followed for 1 year, and consent to longer term follow-up. Primary outcome is physical functioning 12 weeks following surgery, measured by change in Short Form Health Survey (SF-36v2) physical functioning scale. Early and 1 year echo data will be reported by a core laboratory. Estimates of key clinical and health economic outcomes will be reported up to 5 years. The primary economic outcome is cost effectiveness, measured as incremental cost per quality-adjusted life year gained over 52 weeks following index surgery. A favourable opinion was given by Wales REC 6 (16/WA/0156). Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer reviewed publication. ISRCTN13930454.
Author(s): Maier RH, Kasim AS, Zacharias J, Vale L, Graham R, Walker A, Laskawski G, Deshpande R, Goodwin A, Kendall S, Murphy GJ, Zamvar V, Pessotto R, Lloyd C, Dalrymple-Hay M, Casula R, Vohra HA, Ciulli F, Caputo M, Stoica S, Baghai M, Niranjan G, Punjabi PP, Wendler O, Marsay L, Fernandez-Garcia C, Modi P, Kirmani BH, Pullan MD, Muir AD, Pousios D, Hancock HC, Akowuah E
Publication type: Article
Publication status: Published
Journal: BMJ Open
Year: 2021
Volume: 11
Issue: 4
Print publication date: 01/04/2021
Online publication date: 14/04/2021
Acceptance date: 12/03/2021
Date deposited: 09/01/2024
ISSN (print): 2044-6055
ISSN (electronic): 2044-6055
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/bmjopen-2020-047676
DOI: 10.1136/bmjopen-2020-047676
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